| Ilena Rose 2006-08-28, 9:26 pm |
| Excerpts:
The advisory panels analyzed in the report recommended approval 76
percent of the time for new drugs, the report found. For new medical
devices, positive recommendations came 82 percent of the time.
~~~~
An April study found that more than one-fourth of the experts relied
on by the FDA for advice on drugs, including whether to approve new
pharmaceuticals, reported a financial conflict.
2:44 p.m. August 28, 2006
http://www.signonsandiego.com/news/...daadvisers.html
WASHINGTON – The independent panels that the Food and Drug
Administration relies on for advice almost always recommend approving
new drugs and devices, according to a study issued Monday.
The study's author said that raises questions about the independence
of the committees that the FDA counts on for independent safety
feedback on drugs and medical equipment.
The report analyzed the voting patterns of six of 16 FDA drug advisory
committees and five of 18 medical device advisory panels that met from
January 1998 through December 2005. The committees, selected randomly
for analysis, met on 89 occasions to consider new devices and drugs,
as well as new uses for old drugs.
The advisory panels analyzed in the report recommended approval 76
percent of the time for new drugs, the report found. For new medical
devices, positive recommendations came 82 percent of the time.
“Our sense is that the advisory panels have been assumed to be this
important, independent voice. But they don't seem very independent;
they seem more like a rubber stamp,” said study author Diana
Zuckerman, president of the National Research Center for Women &
Families.
The FDA often refers decisions it considers “close calls” to its
advisory committees, which typically meet in all-day sessions that
include public comment sessions. The FDA isn't required to follow the
recommendations of the committees, but usually does.
An FDA spokeswoman said bringing a product before a committee is not a
guarantee of approval.
“Agency decisions regarding product approval are made on the totality
of the data brought forth; while the process may include input and
recommendations from an advisory committee, FDA undertakes a thorough,
independent review of safety and efficacy data relevant to the
product,” spokeswoman Kathleen Quinn said.
The study comes amid stepped-up criticism of the FDA advisory panel
process, including the handling of conflicts of interest among panel
members. The FDA recently announced it would spell out how and why it
grants waivers for outside experts that allow them to serve as FDA
advisers, even when they report financial ties that create the
potential for a conflict.
An April study found that more than one-fourth of the experts relied
on by the FDA for advice on drugs, including whether to approve new
pharmaceuticals, reported a financial conflict.
“When experts serve on FDA's outside advisory committees, they should
be valued for providing independent expertise based on scientific
scrutiny. Consumers are harmed if those advisers are pressured,
directly or indirectly, to recommend approval when they are uncertain
if a product is truly safe or effective,” said Rep. Rosa DeLauro,
D-Conn., a member of the House subcommittee that oversees FDA.
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On the Net: National Research Center for Women & Families:
www.center4research.org/
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